Search Results

The Paruu Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Paruu Wearable Breast Pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breast in home healthcare environment. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The breast milk is collected in a milk collector. The device consists of a pump motor (main unit), milk collection set (flange, diaphragm, duckbill valve, milk collector, flange cover) and accessories (flange insert, charging cable). The milk collection set and flange insert can be purchased separately.

The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The user interface consists of buttons allowing the user to switch between modes and control the vacuum pressure levels, and LED display that providing information on current mode, level, timer and battery status.

The device includes 23 different models, and based on their technological characteristics, are divided into two broad categories – P16 series consisting of models P16, P16-A, P16-B, P16-C, P16-D, and P20 series consisting of models P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D. The models within each series vary in terms of their external color. All device models include 4 working modes (Stimulation, Expression, Two-in-one and Dual frequency for P16 Series and Stimulation, Expression, Lactation, and Traction for P20 Series) and 12 suction levels for each mode.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on 3.7V rechargeable lithium battery. The rechargeable battery can be charged from the external power adapter (not included with the device) through the provided charging cable. All milk contacting components of the device are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Electric Breast Pump (Model YM-8807, YM-8805, YM-8806 and YM-8810) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Electric Breast Pump (Models YM-8807, YM-8805, YM-8806 and YM-8810) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is provided non-sterile and is reusable device intended for a single user in home healthcare environment.

The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The motor unit operates on a rechargeable Lithium battery (3.7V/1400mAh). The rechargeable battery can be charged from the external power adaptor specified in the User Manual (not included) through the provided USB charging cable. The user interface features four buttons (power, mode selection, vacuum level increase and decrease) and an LED display (current mode, level, timer and battery status), allowing the user to navigate between modes and adjust the vacuum pressure.

The subject device includes four models that have same working principle and technology but differ in terms of their appearance, components, and materials. All device models have three modes of operation: Stimulation phase, Expression phase, Simulated sucking Phase, with nine levels in each mode. The Stimulation phase provides high cycle frequency and gentle suction, while the Expression phase provided slower cycles with higher vacuum pressures. The Simulated sucking phase provides a combination of the other two phases - two cycles in Expression phase followed by one Stimulation phase cycle, then three Expressions phase cycles followed by two in Stimulation phase to form one cycle.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. All milk contacting components of the device are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Wearable electric breast pump (Model: YM-8803) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Wearable electric breast pump (Model YM-8803) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. The device is provided not sterile and should be cleaned and disinfected according to the instructions for use.

The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk container.

The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery. The rechargeable battery can be charged from the external power adaptor specified in IFU (not included) through the provided USB charging cable. The user interface features four buttons and an LED display, allowing the user to navigate between modes and adjust the vacuum pressure.

The subject device has two modes: Stimulation and Expression.

N/A

Ask a specific question about this device

The Spectra Platinum is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The Spectra Platinum is an electrically powered breast pump intended for use by lactating women to stimulate lactation and express breast milk. The device is intended for single-user, home use. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time.

The Spectra Platinum operate using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2,000mAh).

The Spectra Platinum is comprised of the following components: Main unit, Power adapter, Tubing, Backflow protector, Wide breast shield, Milk bottle, Screw ring, Cap, Sealing cap for milk bottle, Silicone nipple, Silicone valve. The device is provided non-sterile.

The Spectra Platinum support a single pumping mode in which only one breast is expressed and a dual pumping mode in which both breasts are expressed. The user can switch between Massage Mode and Expression Mode using designated buttons and adjust the vacuum level and cycle speed within each mode.

Spectra Platinum includes the following features:

• Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
• Expression mode: 1-15 level (90-270 mmHg), cycle speeds (38, 42, 46, 50, 54)
• Massage mode: 1-5 level (60-100 mmHg), cycle speeds (70, 80, 90, 100, 105)

The Spectra Platinum operates within these specified parameters.

When the backflow protector is assembled between the pump unit and the wide breast shield, the silicone membrane inside the backflow protector creates a hygienic barrier by preventing air and milk from flowing back into the pump unit. This not only enables safe and hygienic breast pumping, but also protects the pump unit from contamination and potential damage caused by backflow of milk.

N/A

Ask a specific question about this device

The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP434-, BP420-, BP431-, BP432-, BP400-) is a wearable powered breast pump intended to be used by lactating women to express and collect milk from their breast. The device is a non-sterile reusable device to be used by single user. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector. The device is electrically powered through a rechargeable Lithium battery (3.7V) that can be charged using the USB cable provided with the device.

The subject device includes three operating modes, namely - stimulation mode, expression mode, and mixed mode, with 15 levels of operation within each mode and a maximum suction of -315mmHg. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get the milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. The device features a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed during milk expression.

The pump remembers the mode and suction level settings. When restarted, it will resume with the same mode and suction level as when it was last turned off. Each mode's suction level setting is also remembered individually and remains consistent during future use.

The device can be connected wirelessly to a mobile device through Bluetooth and be operated through a dedicated mobile application (Mobile flow). By using the application, users can either select one of three preset operating modes or define a personalized mode. The personalized mode supports personalized sessions, each of which can select its own mode, suction level, and duration. Users can also enable a milk overflow reminder function in the app. Pumping output can also be recorded and tracked by users in the app.

The device is available in one or two pumps in a pack to allow for single/double pumping. The subject device includes an LED display that displays information regarding working mode, running time, suction level, battery status, full milk indicator and Bluetooth indicator. The user interface includes on/off/pause switch, mode selection switch, decrease pumping level, increase pumping level and Toggle button to select breast pump direction to left or right. The subject device includes a diaphragm to prevent milk backflow into the vacuum system as well as software based overflow protection.

The device includes a milk collection set that consists of the following: double-sealed flange (Polyphenylsulfone (PPSU) + Silicone), flange insert, diaphragm assembly, duckbill valve assembly, milk collector (Tritan) and main unit pump motor. Each component can be purchased separately by the user if needed.

N/A

Ask a specific question about this device

The Electric Breast Pump (Models HL-3060, F5113) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (Models HL-3060, F5113) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.

N/A

Ask a specific question about this device

The Electric Breast Pump (Models HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (Models HL-3058, F5112) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
Electric Breast Pump (Models HL-3058, F5112) also has a hot function which provides hear to the users neck for warmth. It does not affect the intended use of the product.

N/A

Ask a specific question about this device

The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump powered by a rechargeable Li-ion battery. It consists of a Pump, Diaphragm, Cup, Valve, Silicone breast shield (flange) and dust cap:

The pump is the core component of the electric breast pump. It generates a cyclic negative pressure (vacuum) to simulate a baby's sucking motion, drawing milk from the breast into the collection system. The pump is electrically driven and controlled via a motor and control unit, typically offering adjustable suction levels and mode. The diaphragm separates the milk collection system from the pump mechanism, preventing breast milk from entering the pump motor and tubing. The cup is the container that collects and stores the expressed breast milk. The valve controls the one-way flow of breast milk. It opens and closes in sync with the suction cycles to allow milk to flow into the cup while preventing backflow. The silicone breast shield, also known as the flange, is the part that comes into direct contact with the breast. It creates a seal around the nipple and areola to enable effective suction. The dust cap covers the opening of the breast shield or milk collection port when the electric breast pump is not in use. It prevents dust, dirt, and other contaminants from entering the breast pump

The electric breast pump has 2 (Primary mode and secondary mode) x 3 modes (Massage Mode, Expression Mode, and Mixed Mode), each mode has 10 adjustable levels:

• Massage Mode provides a vacuum range of 40–190 mmHg and a frequency of 52–110 cycles per minute;
• Expression Mode provides a vacuum range of 80-280 mmHg and a frequency of 19–75 cycles per minute;
• Mixed Mode provides a vacuum range of 80-280 mmHg and a frequency of 6–63 cycles per minute.

N/A

Ask a specific question about this device

Hi bebe super (BT-150B) is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

The Hi bebesuper (model: BT-150B) is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.

BT-150B electrical breast pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). BT-150B electrical breast pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery.

BT-150B electrical breast pump has three operating modes: massage mode, expression mode and program mode to save pressure level and cycle level and their mode (massage or expression) and their running time. Sixteen (16) vacuum pressure levels are available for operating mode ad massage mode. One cycle speed level is available for massage mode and three (3) cycle speed levels are available for expression mode. The device is capable of providing suction up to -270 mmHg.

The subject device is a modified version of BT-150S model of K200675. Compared to the predicate device, the following changes are made.

• Power source change. Both AC-powered mode and battery-powered mode are available.
• Vacuum pressure and cycle speed.
• User interface: Compared to the predicate device, the lamp button is removed, increase cycle speed button and decrease cycle speed button are combined as one cycle level change button, and the function of each button is modified.
• Dual motors system: The subject device includes dual pumps while the predicate device includes a single pump. Compared to the predicate device, a sub board has been removed and both pumps are connected to the main board.

N/A

Ask a specific question about this device

The Magic InBra™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.

The Magic InBra™ powered breast pump is intended for a single user.

This breast pump is intended to be used in a home environment.

The Magic InBra wearable breast pump is a single user pump to be used by lactating women to express and collect milk from their breasts in the home environment. Magic InBra is designed to fit most breast shapes and nursing bras allowing hands-free pumping. The pump is intended to be used by a single user for pumping on one breast with one Magic InBra breast pump or on both breasts at the same time with two Magic InBra breast pumps.

An optional smartphone application (app) for iPhone and Android, called "Medela Family Pump Control", connects to the breast pump via Bluetooth and, once connected, allows the user to control the breast pump remotely.

N/A

Ask a specific question about this device